This invention relates to human blood aspiration assemblies and methods of their use. It is necessary and indeed critical to frequently draw blood from patients having a broad variety of illnesses. Cumulative and repetitive blood sampling must be conducted in a number of instances. Such blood samples are often drawn through tubing systems that are connected to indwelling catheters to avoid the pain, inconvenience and potential complications of frequent penetration of the patient's skin.
These tubing systems are often maintained in near-constant direct fluid communication with the vasculature through the catheter, and are used for monitoring pressures within the vasculature, for fluid administration, or simply for maintaining a channel for easy access to the vascular system.
These tubing systems generally contain an electrolyte or dextrose solution when in fluid connection with the vasculature. The reflux of blood into such tubing systems is prevented by maintaining fluid pressure within such tubing equal to, or higher than, that in the vessel in which the catheter dwells. This pressure avoids thrombotic occlusion of the tubing system or catheter while allowing the system to remain patent, or unobstructed despite near constant fluid communication with the vascular system.
In the prior art, such an above-described system can have a proximal tubing segment portion which is closest to the high pressure source, a distal tubing segment which is closer to the catheter, and a channel which opens to the atmosphere (atmospheric channel). This channel is usually capped. A three-way stopcock is connected to the channel and is in line with the tubing. Normally the stopcock connects the proximal tubing to the distal tubing, with the atmospheric channel closed.
When a blood sample is desired, the cap covering the atmospheric channel is removed. A separate syringe is moved by the hand and its neck connected to the atmospheric channel. The stopcock is then turned to open the distal tubing to the syringe. This places the vascular system in direct fluid communication with the syringe. Fluid can then be aspirated from the tubing and the vascular system into the syringe. Upon aspiration, the initial liquid entering the syringe is the resident fluid in the distal tubing segment.
After this, blood, diluted with such resident fluid, will enter the syringe. Finally, after all the resident fluid has been aspirated into the syringe, undiluted blood will enter the syringe and will entirely fill the distal tubing. The stopcock is then closed to the atmospheric channel, and the first syringe is detached from the stopcock. The first syringe is in many uses discarded. With premature infants or small babies, the diluted blood in the first syringe may be reinjected after the blood sample for testing is obtained. But there is a risk of clot formation, thrombosis or infection when this attempt to save blood is made.
A second syringe then must be attached to the atmospheric channel and the stopcock is reopened to the second syringe to thereby place the syringe in fluid communication with the distal tubing that is filled with undiluted blood.
Undiluted blood is then aspirated into the second syringe from the distal tubing and the vasculature in the amount desired for analysis. When sufficient blood is obtained, the stopcock is closed to the second syringe. The second syringe is removed. At this point in some cases, to save blood, the diluted blood is reinjected from the first syringe back into the stopcock with the aforesaid hazards of thrombosis, clotting and infection. The stopcock is thence commonly closed to the distal tubing and opened to produce liquid communication between the proximal tubing and the atmospheric channel.
Following this, the pressure in the more proximal tubing is increased to allow fluid to escape from the proximal tubing out the atmospheric channel to clear residual blood from this channel. Next, the cap is replaced over the atmospheric channel. The stopcock is then closed to the atmospheric channel and opened to the distal tubing segment to reestablish the original fluid communication between the proximal and distal tubing. Following this, the pressure is again increased in the proximal tubing so that fluid will enter the distal tubing from the proximal tubing, thereby forcing the fluid within the distal tubing back into the vascular system through the catheter. As a result, the tubing system again becomes entirely filled with electrolyte or dextrose solution.
Several problems exist in the prior art. First, the procedure often requires the initial sample of blood (which is obtained to clear the resident fluid from the tubing) to be discarded, since it is diluted by the withdrawal procedure. This results in a loss of blood from the patient which is cumulative over many sample aspirations. Eventually, this can produce anemia and could necessitate a blood transfusion to replace such cumulative blood losses. (See "Phlebotomy For Diagnostic Laboratory Tests In Adults, Pattern Of Use and Effect On Transfusion Requirements", New England Journal Of Medicine, Vol. 31, p. 1233, 1986; and "Medical Vampires" (Editorial), New England Journal Of Medicine, Vol. 31, p. 1250, 1986).
Patients who require many blood samples to be taken during protracted illnesses or after severe trauma may require transfusions which would not otherwise be necessary, and may therefore be subject to the increased risk of blood transfusion related infectious diseases such as hepatitis and A.I.D.S., for example.
Moreover, the stopcock in conventional systems must frequently be open to a channel which is intermittently exposed to the atmosphere. Hence, there is a significant risk of microorganisms contaminating the stopcock and thereby entering the vascular system producing infections which may be extremely serious and even fatal. (See "Stopcock: Bacterial Contamination and Invasive Monitoring Systems", Heart & Lung, Vol. 8, p. 100, 1979; and "Stopcock Contamination In An ICU", American Journal of Nursing, Vol. 75, p. 96, 1975).
An additional problem is the potential for dilutional error introduced into the blood samples obtained. This results when hospital personnel fail to remove enough blood to adequately clear the resident fluid from the indwelling catheter and its connected tubing. This has been reported in the medical literature to cause error in both measured blood gas values and hematocrit concentrations. Such erroneous hematocrit values have been noted as a potential source of unnecessary blood transfusions in surgical patients. It has been noted that the first syringe must withdraw a volume of intravenous solution and blood that is six times the volume of the tubing distal to the stopcock. (See "Errors In Intraoperative Hematocrit Determination", Anesthesiology, Vol. 45, p. 357, 1976; and "Effect of Sample Dilutions on Arterial Blood Gas Determinations", Critical Care Medicine, Vol. 13, p. 1067, 1985).
Furthermore, many present conduit systems provide internal diameters which vary abruptly over the length of the conduit. The abrupt change in diameters results in areas where fluid flow is not streamlined, and where pockets of fluid can gather while the main fluid flow goes onward. Accordingly, when blood is drawn into the system from the catheter to displace the resident fluid, pockets of residual resident fluid may remain within the conduit channel. This can dilute any aspirated blood samples later drawn.
Another shortcoming is that the present method of obtaining undiluted blood samples from fluid-filled tubing connected with the vascular system is cumbersome and inconvenient.
With regard to the needle apparatus and special aspirator plug aspect of the invention, the risk of accidental needle puncture has been well known for a long time, and for more than a decade has been known as a common cause of infection of hospital personnel with hepatitis virus. Such needle punctures now are accompanied by the risk of infection with the AIDS virus. The risk of needle puncture is especially acute during the time when needles are inserted into a fluid-filled tubing that is connected to an indwelling vascular catheter to obtain a blood sample. Tubing systems heretofore used have often included septums for blood sampling or medication injection. These septae are designed to be punctured by sharp needles to allow entry of the needle into the tubing so that the needle tip is in fluid communication with the liquid within the tubing.
Such insertion of the needle into the tubing allows a blood sample to be aspirated from the tubing, or allows injection of medication into the tubing. The needles used to penetrate these septae are sharp and can easily penetrate human skin with even casual inadvertent contact. In addition, misdirection of the needle tip against the skin with the same force required to penetrate into the septum will invariably cause skin puncture accompanied by the risk of a fatal or extremely hazardous infection.
Hence, there has long been a need to solve the problem of accidental needle sticks associated with penetrating a septae in order to withdraw blood or inject medication.